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Above- versus below-elbow casting for non surgical treatment for distal radius fractures in adults. Randomized controlled trial.

Grant number: 19/04546-4
Support Opportunities:Regular Research Grants
Duration: July 01, 2019 - December 31, 2021
Field of knowledge:Health Sciences - Medicine - Surgery
Principal Investigator:João Carlos Belloti
Grantee:João Carlos Belloti
Host Institution: Escola Paulista de Medicina (EPM). Universidade Federal de São Paulo (UNIFESP). Campus São Paulo. São Paulo , SP, Brazil


BACKGROUND- A variety of cast options are available for the non-surgical treatment of distal radius fractures (DRF) in adults. However, the literature is inconclusive regarding the need to immobilize the elbow joint after reduction in order to prevent rotation of the forearm in order to maintain the reduction of DRF. This study aimed to evaluate the best method of immobilization between above-elbow (AE) and below-elbow (BE) cast groups at the end of six-month follow-up.METHODS - This is a randomized clinical trial with parallel groups and a blinded evaluator. There are two non-surgical interventions: AE and BE. Patients will be randomly assigned. A hundred twenty eight consecutive adult patients with acute (up to 7 days) displaced DRF of type A2, A3, C1, C2 or C3 by the Arbeitsgemeinschaftfür Osteosynthesefragen (AO) classification will be included. The primary outcome will be the maintenance of reduction by evaluation of radiographic parameters and Disabilities of the Arm, Shoulder and Hand Questionnaire(DASH). Secondary outcomes include function measured by Patient Rated Wrist Evaluation (PRWE), pain measured by the Visual Analogue Scale (VAS), objective functional evaluation (goniometry and dynamometry) and rate of complications. Evaluations will be performed at 1, 2, 3, 4, 6, 8, 12 and 24 weeks. For the Student´s t-test, a difference of 10 points in DASH score, with 95% confidence interval, a statistical power of 95%, and 20% sampling error. We consider an extra 10% for balancing follow up losses results in 64 patients per group. (AU)

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
OKAMURA, ALDO; DE MORAES, VINICIUS YNOE; NETO, JORGE RADUAN; TAMAOKI, MARCEL JUN; FALOPPA, FLAVIO; BELLOTI, JOAO CARLOS. No benefit for elbow blocking on conservative treatment of distal radius fractures: A 6-month randomized controlled trial. PLoS One, v. 16, n. 6, . (19/04546-4)

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